Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

ConditionOpioid Use Disorder

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBrigham and Women's Hospital

About this trial

This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking adults aged 18 and above.

diagnosis of opioid use disorder.

Self-reporting use of illicit opioids in >21 days in the prior 30 days.

Provide urine toxicology testing positive for fentanyl at baseline.

Disqualifiers

Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.

Received buprenorphine or methadone treatment in prior 30 days.

Current diagnosis of alcohol or sedative/hypnotic use disorder.

Positive urine drug screen for benzodiazepines, alcohol and or methadone.

Trial design

Design model

Sequential

Treatments tested in this trial

Extended-release Buprenorphine
Drug
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: 16mg Extended-Release BuprenorphineExperimental treatment 1 intervention

Group B: 24mg BuprenorphineExperimental treatment 1 intervention

Group C: 32mg BuprenorphineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety and tolerability of XR-Buprenorphine

The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW, which will be assessed using the COWS. An increase in the COWS score by 8 or more with the total score exceeding 13, within 4 hours will be considered BPOW.

Time frame

For the duration of the inpatient admission, lasting 24 hours after receipt of study drug.

Plasma-concentration curves (AUC) of buprenorphine.

The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in anticoagulant Vacutainer tubes via venipuncture at baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection. Samples will be centrifuged and frozen until analysis.

Time frame